FDA.reportPublic FDA data

Screwdriver L20 ASTRA TECH

Primary DI
D800SIAK4007L20
Brand
Screwdriver L20 ASTRA TECH
Company
ZIRKONZAHN SRL
Model
SIAK4007L20
Device description
Content: 1 piece Screwdriver for fixing and removing ASTRA TECH screws Use with ratchet wrench SIAK0001 only
Published
2021-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800SIAK4007L20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+390474066660info@zirkonzahn.com

Regulatory Flags#

DUNS number
564251911
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D800FMAA05030Colour Liquid A4 (20 ml)FMAA05032026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)FMAA06032026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)FMAA07032026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)FMAA08032026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)FMAA09032026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)FMAA10032026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)FMAA11032026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)FMAA12032026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)FMAA13032026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)FMAA14032026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)FMAA15032026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)FMAA16032026-05-28
D800FMAA17030Set Colour Liquid (20 ml)FMAA17032026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)FMAA19032026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)FMAA20032026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)FMAA31022026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)FMAA31032026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)FMAA32022026-05-28

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Primary DI, Brand, Company table
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